Inventory of National Practices on Standards, Technical Regulations
and Conformity Assessment in the Western Hemisphere
Introduction
The Free Trade Area of the Americas (FTAA) Working Group on Standards and Technical
Barriers to Trade which resulted from the established by the Western Hemisphere's Trade
Ministers in July 1995 was given a work program containing four elements:
- "recommend specific ways to enhance transparency, especially in standards development;
- compile information on the bodies that exist which are charged with conformity assessment to technical regulations in the Hemisphere, and those organizations that accredit such bodies;
- recommend methods to promote understanding of the WTO Agreement on Standards and Technical Barriers to Trade, including through technical assistance; and
- make recommendations on product testing and certification, with a view to mutual recognition
agreements."
Trade Ministers also acknowledged that, while the countries themselves would have primary
responsibility for carrying out the Denver mandate, individual working groups were encouraged
to draw upon the resources of the Tripartite Committee for technical assistance (as composed
of the Organization of American States, the Inter-American Development Bank and the U.N.
Economic Commission for Latin America and the Caribbean). Within the Tripartite Committee it
was decided that assistance to the Working Group on Standards and Technical Barriers to
Trade would be the responsibility of the OAS.
The FTAA Working Group on Standards and Technical Barriers to Trade met for the first
time on August 31-September 1, 1995 in Ottawa. Canada was designated Chair of the Working
Group. The Working Group has subsequently met in December 1995, February 1996, June 1996
and December 1996.
To comply with components a) and b) of the Work Program, the Working Group asked that an
inventory be established of national practices in the area of standards, technical regulations
and conformity assessment procedures by countries of the Western Hemisphere. An outline for the
inventory was circulated and responses were furnished by 30 of the 34 countries in the FTAA
process. The inventory was prepared by the Trade Unit of the Organization of American States.
The purpose of this inventory is to enhance transparency around existing national practices
of FTAA participants in these areas and to thus assist in furthering the process of trade
liberalization and economic integration within the Western Hemisphere.
The inventory is designed to facilitate a better understanding by policy officials,
standards experts and industry representatives, as well as multilateral and regional
standardizing bodies, of the operation of national entities responsible for the elaboration and
setting of standards, technical regulations and conformity assessment in the participating
countries of the FTAA Working Group. It also contains information on national practices
relating to measurement and metrology, inspection and testing, and certification and
accreditation of products and quality systems. A list of enquiry points for the purpose of
providing information on national standards and technical regulations is found at the end of
the Inventory.
The information contained in the Inventory allows the following summary observations to
be made with respect to the state of standards activities and development in the Western
Hemisphere:
-
Among the 34 participants in the FTAA process, 22 have a national standardizing body
or bodies. Of these, 10 are government entities, while 9 are private entities and 3 are mixed
bodies. In a few cases (Brazil, Canada, Mexico, the United States), one body acts as a
coordinator for the elaboration of standards by numerous government and private sector
standards development organizations.
- The number of national standards which have been elaborated by national standardizing
bodies in countries of the Western Hemisphere varies widely: from a few hundred in some
countries of the Caribbean and Latin America to an estimated 95,000 in the United States.
Compliance with these national standards is voluntary.
- Technical regulations are elaborated by various government ministries, departments, state
secretariats and/or other agencies under them within each FTAA participant country, depending
upon the product sector concerned which may be: information technology and communication
equipment; chemicals; building/construction regulations; drugs and pharmaceutical products;
environmental regulations; medical devices; transportation equipment; processed and
unprocessed food; or consumer protection, health and safety regulations. These technical
regulations carry with them obligatory compliance.
- Membership in the International Standards Organization (ISO) is held by 22 national
standardizing bodies in the region. Of the FTAA participants, 19 are members of the Pan
American Commission on Technical Standards (COPANT), the regional standardizing body in the
Western Hemisphere.
- At the multilateral level, nearly all FTAA participants are Members of the World Trade
Organization (WTO)and of the Committee on Technical Barriers to Trade, which oversees the
WTO Agreement on Technical Barriers to Trade. At the regional level, most FTAA participants
are members of one or more trade and integration arrangements, many of which contain provisions
and/or have sponsored activities to coordinate common policies on standards development and
conformity assessment procedures for members.
- When developing national standards, 23 countries specified that they use international
standards as a reference and/or attempt to directly incorporate international standards at
the national level.
- Several referenced the ISO/IEC Guide 59 or the "Code of Good Practices for Standardization" as
the basis for the elaboration of standards.
- In the Western Hemisphere 17 countries have metrology laboratories for the purpose of carrying
out measurement and calibration activities. Of these, 7 countries have a separate national
metrology center or service. The Inter-American Metrology System (SIM) carries out hemispheric
cooperation among 25 countries.
- Many countries are members of the International Organization of Legal Metrology (OILM), the
Convention du Metre and the International Bureau of Weights and Measures (BIPM), and 15
countries stated that these international standards were used as the formal basis for
measurement and for other activities in practical metrology.
- For the purpose of product testing for conformity assessment purposes, most countries have
laboratories for product testing and many have a network of bodies that engage in
inspection and testing. However, only 9 countries presently have the capacity and system in
place for the accreditation of laboratories and inspection agencies. Another 3 countries
stated that the government was in the process of drafting legislation to create such capacity
in the future. Of the countries with accreditation programs in place, all 9 stated that these
functioned in accordance with the international ISO/IEC Guides on accreditation, certification
and inspection activities.
- At present only four mutual recognition agreements have been signed between countries of the
Western Hemisphere, namely between the Standards Council of Canada (SCC) and the National
Voluntary Accreditation Program (NVLAP) of the U.S. National Institute for Standards and
Technology (NIST) for laboratory testing, between the SCC and the U.S. American Association for
Laboratory Accreditation (A2LA) for laboratory accreditation, and between Colombia and Venezuela,
and Brazil and Uruguay, for product testing. A few memoranda of understanding have been
signed for the purpose of technical exchange and cooperation.
- With respect to certification, 17 countries have systems in place for the certification of
testing and quality control activities. Most of these programs cover both certification of
products as well as certification of quality system registration. However, the two are usually
administered separately and are often carried out by private sector bodies.
- No formal affiliations or agreements exist at present between national bodies in the Western
Hemisphere that accredit registration organizations.
- The international guides developed by ISO/IEC are used by 16 countries as the basis for
certification of products and processes and quality systems, as well as for the procedures
used to accredit certification entitites, where relevant.
- Enquiry points for the dissemination of information on standards, technical regulations and
conformity assessment procedures as required under the WTO Agreement on Technical Barriers
to Trade have been established by 14 of the FTAA participants. The addresses and contact numbers of these enquiry points are listed in Annex I.
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